accelerated radiation therapy after surgery in treating patients with breast cancer

Conditions: Inflammatory Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Carcinoma; Mucinous Ductal Breast Carcinoma; Papillary Ductal Breast Carcinoma; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Tubular Ductal Breast Carcinoma

Summary: this phase ii trial studies how well giving accelerated radiation therapy (rt) after surgery works in treating patients with breast cancer. rt uses high energy x rays to kill tumor cells. giving rt after surgery may kill any remaining tumor cells

primary objectives: i. freedom from local failure and freedom from regional failure. secondary objectives: i. acute toxicity and late toxicity using previously published toxicity scales. ii. to identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy. iii. to correlate toxicity, cosmesis, and local control with molecular markers. outline: patients undergo hypofractionated accelerated rt over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed * american joint committee for cancer (ajcc) stage iia - iiic (pathologic stage t0n1-3, t1n1-3, t2n1-3, t3n0-3, t4n0-3, all m0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (t4d) is allowed * patients with locally advanced breast cancer on clinical exam and diagnostics ( \> 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed * multifocal/multicentric disease is allowed * negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin * tamoxifen, arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician * chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above * chest wall reconstruction is allowed * the patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy * signed study-specific informed consent form prior to study entry * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * patient with distant metastases (m1) * patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma * patient with t1n0 or t2n0 disease * prior radiation therapy to the chest * patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * patients with co-existing medical conditions with life expectancy \< 2 years * patients with psychiatric (with the possible exception of incompetence as defined by new jersey \[nj\] law) or addictive disorders that would preclude obtaining informed consent * other malignancy, except non-melanomatous skin cancer, \< 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous * women who are pregnant or lactating due to potential exposure of the fetus to rt and unknown effects of rt to lactating females * women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment